Cleared Traditional

K992846 - HICHEM TOTAL PROTEIN REAGENT

K992846 is an FDA 510(k) clearance for HICHEM TOTAL PROTEIN REAGENT, manufactured by Elan Holdings, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K992846 · Elan Holdings, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
55d
Days
Class 2
Risk

K992846 is an FDA 510(k) clearance for the HICHEM TOTAL PROTEIN REAGENT. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on October 18, 1999 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elan Holdings, Inc. devices

FDA 510(k) Submission Details - K992846

510(k) Number K992846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1999
Decision Date October 18, 1999
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEK Device Classification - Class 2, Special Controls

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEK Biuret (colorimetric), Total Protein

All 100
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K992846.
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
K973108 · Diagnostic Chemicals , Ltd. · Mar 1998
CARESIDE TOTAL PROTEIN
K980042 · Exigent Diagnostics, Inc. · Feb 1998
TOTAL PROTEIN OR TP
K971524 · Carolina Liquid Chemistries Corp. · May 1997
CSF/URINE TOTAL PROTEIN
K961864 · Teco Diagnostics · Oct 1996
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
K955905 · Solarcare Technologies Corp,Inc. · May 1996
TOTAL PROTEIN REAGENT
K955936 · Derma Media Lab., Inc. · Mar 1996